Safety Notices

HPRA Safety Notice Communication

We publish notices relating to the safety and/or quality of medical devices. The issues covered by these notices will range from quality defect information to product recalls, to updated information on the appropriate usage of the medical devices.

View the current safety notices for medical devices below.

If you would like to receive copies of these notices at the time of publication via e-mail please forward an e-mail request to devicesafety@hpra.ie.

Learn more about HPRA safety notices.

Manufacturer's Field Safety Notices

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market.

The HPRA puts these notices on our website for information.

Learn more about field safety notices.

Field Safety Notices - Outstanding Actions

When a field safety notice is issued by a medical device manufacturer on the Irish market, the HPRA seek confirmation from the manufacturer that the required action has been completed. Sometimes, completion of the action is delayed or hampered due to issues experienced by the manufacturer. The HPRA publishes details of field safety notices that have been circulated to the Irish market for which action remains outstanding.

Learn more about field safety notices.

Date Title Type
17/12/2013 Patterson Walking Frames (wheeled and non-wheeled) Advisory
08/11/2013 NIPPY 3 ventilator, NIPPY JUNIOR ventilator, NIPPY ST ventilator, NIPPY S ventilator Advisory
18/09/2013 Zimma Walking Frames fitted with Wheeled Extension Legs Advisory
17/09/2013 Birdie & Flamingo Patient Lifters Advisory
02/09/2013 HeartStart XL with M3516A batteries of lot number prefix ‘LK’ Advisory
30/07/2013 Trophy IRIX 70, IRIX 708, NOVELIX 6510 and ORAMATIC 558 Advisory
11/07/2013 SynchroMed® II and SynchroMed EL Implantable Drug Pumps Advisory
13/06/2013 Gas Tamponades: EasyGas; SF6, C2F6, C3F8 Advisory
17/05/2013 LIFEPAK CR Plus and LIFEPAK EXPRESS Advisory
15/04/2013 OneTouch Verio Pro and OneTouch Verio IQ Blood Glucose Meters Advisory
27/03/2013 ALL HOSPIRA GEMSTAR FAMILY OF INFUSERS Advisory
26/03/2013 ALL HOSPIRA PLUM A+/A+3 FAMILY OF INFUSERS Advisory
05/03/2013 Use of Luer adaptors with Needle-Free Connection Systems and prefilled Syringes Advisory
18/12/2012 IMB re-issues leaflet on Automated External Defibrillators (AEDs) Advisory
17/12/2012 Defibtech DDU-100 series AED marketed under the brand names Lifeline AED, ReviveR AED and Lifeforce AED Advisory
17/12/2012 Samaritan PAD 300/PAD 300P Automated External Defibrillators Advisory
08/10/2012 WISPA PORTABLE HOIST AND ATTACHMENT HANDLE Advisory
10/09/2012 HeartStart MRx Advisory
06/09/2012 ArjoHuntleigh Passive Patient Lifts and Ceiling Lifts with four-point hanger bars intended for use with Passive Clip Slings and Clip Flite Slings Advisory
28/08/2012 Animas Insulin Pump (IR 1200, 2020, One Touch Ping, Vibe) Advisory